An internal audit of payment practices in Eastern Europe has revealed payments for elaborate travel for physicians in exchange for approval and prescription of your products. What should you do? Mara Senn offers some advice.

Pharma has had a year to address MHRA’s update to the definition of a critical GCP inspection finding to include trial master files that are “not readily available or accessible”. How has it fared? Rik van Mol reports.

Europe

There are evident challenges for pharma in the ongoing Greek crisis. But, writes Reflector, there are some less evident challenges which may, over time, prove to be more difficult for the industry to cope with.

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

FDA has launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA), setting the stage for FDA to hear the views of patient, consumer and health professional representatives. Jill Wechsler reports.

Regulatory

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

Whether a brand is preparing to launch a new product, or taking a reinvigorated one back to market, it is widely accepted that those who form the emotional connection with customers are most likely to succeed.